Decayed TeethNCT07259265
Vital and Non-vital Posterior Teeth Restored With Onlays and Single Crowns Using Three Different Restorative Materials.
A study testing Crown preparation and Onlay preparation in people with Decayed Teeth, run by Dr. med. dent. Malin Strasding at 1 site in Switzerland.
Trial summary
The objective of this study is to assess the survival rate and the biological and technical outcomes of onlays and single crowns made out of different restorative materials on vital and non-vital teeth. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Decayed Teeth
- What is being tested?
- Crown preparation and Onlay preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Mar 2019to 6 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Subjects with the need for a fixed reconstruction in premolar and molar region with indication for either crown or onlay.
- min. 18 years of age and ≤ 80 years
- Patient with physical status PS1 and PS2 (according to Physical Status Classification System of the American Society of Anesthesiologists; Attachment 5)
- Capable of providing written informed consent
- Absence of any active periodontal and pulpal disease
Who cannot join
- Presence of conditions requiring chronic routine prophylactic use of antibiotics or prolonged use of steroids e.g. history of rheumatic heart disease, bacterial endocarditis, cardiac vascular anomalies, prosthetic joint replacements, etc.
- Patients with history of renal failure, bleeding disorders, metabolic bone disorder, uncontrolled endocrine disorders, HIV infection, Hepatitis
- History of neoplastic disease requiring the use of radiation or chemotherapy
- Inability to perform adequate oral hygiene
- Significant reduced saliva flow rate
- Unable or unwilling to cooperate for the trial period
Show all 13Show fewer
- Allergy to any components of the reconstruction materials and cements
- Alcohol or drug abuse
- Pregnant or lactating women
- Specific criteria:
- Root caries / root canal caries
- Extreme short dental arch (eSDA)
- Severe bruxism or clenching habits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longterm Outcomes of Vital and Non-vital Posterior Teeth Restored With Onlays and Single Crowns: a Randomized, Controlled, Clinical Trial
The objective of this study is to assess the survival rate and the biological and technical outcomes of onlays and single crowns made out of different restorative materials on vital and non-vital teeth. The onlays are made either out of a lithium-disilicate glass ceramic (E.max CAD, Ivoclar Vivadent), hybrid ceramic (VITA ENAMIC, VITA Zahnfabrik) or out of a lithium aluminosilicate glass ceramic reinforced with lithium disilicate (N!ce, Straumann). The crowns are made either out of lithium aluminosilicate glass ceramic reinforced with lithium disilicate (N!ce, Straumann), hybrid ceramic (VITA ENAMIC, VITA Zahnfabrik) or lithium-disilicate glass ceramic (E.max CAD, Ivoclar Vivadent).
- Conditions
- Decayed Teeth
- Being tested
- Crown preparation, Onlay preparation
- Keywords
- onlay, crown, partial coverage, full coverage, ceramic restoration
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crown preparationProcedure or surgery
The conventional crown preparation will be performed.
Onlay preparationProcedure or surgery
A defect-oriented tooth preparation is performed for an onlay restoration.
| Study group | Role | What they receive |
|---|---|---|
| Crown restoration | Active comparator | The tooth is restored with a conventional, full-coverage crown. Receives: Procedure: Crown preparation |
| Onlay restoration | Experimental | The tooth is restored with a defect-oriented onlay. Receives: Procedure: Onlay preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration survival
Survival of the inserted restorations
Measured: 5 years
Secondary outcomes (7)
Fractures of the restorations.
Any chipping (uncritical fractures) or critical fractures will be assessed.
Measured: 5 years
Tooth vitality
The presence or absence of tooth vitality will be assessed by means of vitality test using cold spray.
Measured: 5 years
Biological outcome - presence of secondary caries
Biological outcome - presence of secondary caries - of the treated teeth using magnification loops, a dental probe and radiographs.
Measured: 5 years
Biological outcome - Bleeding on Probing
Bleeding on probing measures of the treated tooth using a periodontal probe.
Measured: 5 years
Biological outcome - Plaque index
Assessment of the Plaque index of the treated tooth using a dental probe.
Measured: 5 years
Biological outcome - tooth fractures
Assessment of tooth /root fractures using a dental probe and magnification loops.
Measured: 5 years
Biological outcome - pocket probing depth
The pocket probing depth will be assessed in millimeters with a periodontal probe with 1mm distances.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start4 Mar 2019
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decayed TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. med. dent. Malin Strasding
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Straumann AG, Ivoclar Vivadent AG
- Responsible party
- Sponsor-investigator, Dr. med. dent. Malin Strasding, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259265
- Sponsor's protocol ID
- GTC Study
- Status last verified
- Nov 2025
- First submitted
- 19 Dec 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: because of private patient data .
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Outcomes of Vital and Non-vital Posterior Teeth Restored With Onlays and Single Crowns: a Randomized, Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT07259265
- Acronym / sponsor ID
- GTC Study
- Conditions
- Decayed Teeth
- Keywords
- onlay, crown, partial coverage, full coverage, ceramic restoration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dr. med. dent. Malin StrasdingUniversity, hospital or other
- Collaborators
- Institut Straumann AG, Ivoclar Vivadent AG
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the survival rate and the biological and technical outcomes of onlays and single crowns made out of different restorative materials on vital and non-vital teeth. The onlays are made either out of a lithium-disilicate glass ceramic (E.max CAD, Ivoclar Vivadent), hybrid ceramic (VITA ENAMIC, VITA Zahnfabrik) or out of a lithium aluminosilicate glass ceramic reinforced with lithium disilicate (N!ce, Straumann). The crowns are made either out of lithium aluminosilicate glass ceramic reinforced with lithium disilicate (N!ce, Straumann), hybrid ceramic (VITA ENAMIC, VITA Zahnfabrik) or lithium-disilicate glass ceramic (E.max CAD, Ivoclar Vivadent).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crown restoration | Active comparator | Procedure: Crown preparationThe tooth is restored with a conventional, full-coverage crown. |
| Onlay restoration | Experimental | Procedure: Onlay preparationThe tooth is restored with a defect-oriented onlay. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Subjects with the need for a fixed reconstruction in premolar and molar region with indication for either crown or onlay.
Key exclusion criteria (13 listed)
- Presence of conditions requiring chronic routine prophylactic use of antibiotics or prolonged use of steroids e.g. history of rheumatic heart disease, bacterial endocarditis, cardiac vascular anomalies, prosthetic joint replacements, etc.
- Patients with history of renal failure, bleeding disorders, metabolic bone disorder, uncontrolled endocrine disorders, HIV infection, Hepatitis
- History of neoplastic disease requiring the use of radiation or chemotherapy
- Inability to perform adequate oral hygiene
- Significant reduced saliva flow rate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crown preparationThe conventional crown preparation will be performed. | Procedure or surgery | Crown restoration |
| Onlay preparationA defect-oriented tooth preparation is performed for an onlay restoration. | Procedure or surgery | Onlay restoration |
Primary outcome
Restoration survival
Time frame: 5 years
Survival of the inserted restorations
7 secondary outcomes
Fractures of the restorations.
Time frame: 5 years
Tooth vitality
Time frame: 5 years
Biological outcome - presence of secondary caries
Time frame: 5 years
Biological outcome - Bleeding on Probing
Time frame: 5 years
Biological outcome - Plaque index
Time frame: 5 years
Biological outcome - tooth fractures
Time frame: 5 years
Biological outcome - pocket probing depth
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No. because of private patient data .
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crown preparation and Onlay preparation in people with Decayed Teeth, run by Dr. med. dent. Malin Strasding at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.